The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for Accutip Cover.
| Device ID | K132549 |
| 510k Number | K132549 |
| Device Name: | ACCUTIP COVER |
| Classification | Tonometer, Manual |
| Applicant | ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
| Contact | Adam Pickholtz |
| Correspondent | Adam Pickholtz ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-14 |
| Decision Date | 2014-04-23 |
| Summary: | summary |